Checklist During Multidisciplinary Daily Visits and Clinician Prompting for Reduction of Mortality in Intensive Care Units: A Cluster Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 13,637
- 试验地点
- 1
- 主要终点
- In-hospital mortality truncated at 60 days
研究概览
简要总结
CHECKLIST-ICU will be a cluster randomized trial to ascertain whether the use of an intervention including 1) checklists with assessment of daily goals during the multidisciplinary visit, and 2) clinician prompting can reduce in-hospital mortality of patients admitted to intensive care units (ICUs).
The investigators also aim to describe participant ICUs in terms of the standards for intensive care units proposed by the Brazilian National Health Agency (ANVISA).
详细描述
Cluster randomized trial involving ICUs in Brazil. ICU is the unit of randomization.
The trial will have two stages:
-
Stage I - Baseline data.In this stage we will:
-
Apply "Safety Attitudes Questionnaire" for the employees of the participating ICU.
-
Characterize participant ICUs in terms of the standards (RDC nº7/2010, RDC nº26/2012 e RDC nº 63/2011) for intensive care units proposed by the Brazilian National Health Agency (ANVISA)
-
Characterize patients: we will collect data from 60 consecutive critically ill patients from each participant ICU to describe adherence to measures aimed at avoiding ICU complications and clinical outcome measures.
-
Stage II - Intervention: This is the main stage for data analysis. ICUs will be randomly assigned to an experimental or control group. The experimental group should use a multi-item verbal checklist including assessment of daily goals during the multidisciplinary visits plus clinician prompting. We will collect data from 60 additional patients for each ICU in both study groups and apply "Safety Attitudes Questionnaire".
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •for clusters:
- •Intensive care units, except dedicated coronary care units/cardiac intensive care units and step-down units;
- •Must have multidisciplinary daily rounds or coordinators agree to implement daily rounds, including at least one physician and one nurse, conducted at least on week days.
排除标准
- •for clusters:
- •We will exclude ICUs that systematically apply checklists in the multiprofessional daily visit. We define systematically applied checklist when all the following criteria are met:
- •Content: structured evaluation following a digital or printed document of multiple items focused on prevention of common ICU complications (eg. ventilator-associated pneumonia, stress ulcer, venous thromboembolism and/or catheter-associated bloodstream infection) and/or explicit assessment of daily goals;
- •Time frame: daily application of checklist for at least 30 days
- •Periodicity: at least 3 days per week
- •How is applied: verbal, observational (1 professional check all items), with or without written register
- •Patient inclusion criteria:
- •Adult patients (≥18 years-old) with anticipated ICU length of stay > 24 hours.
- •Patient exclusion criteria;
- •High probability of death within 24 hours or patients admitted in ICU for palliative care only;
- •Suspected or confirmed brain death.
研究组 & 干预措施
Daily checklist and clinician prompting
Checklist during multidisciplinary daily visits + clinician prompting + audit & feedback
干预措施: Daily checklist and clinician prompting (Behavioral)
Usual care
Usual care
结局指标
主要结局
In-hospital mortality truncated at 60 days
时间窗: Hospital discharge; average of 20 days; follow-up limited to 60 days
Follow-up will be limited to 60 days after ICU admission. Patients who are still in the hospital after 60 days of ICU admission will be considered as discharged alive.
次要结局
- Head of the bed elevated at 30°(Every 3 three days, from ICU day 2 to 17)
- Adequate prophylaxis for venous thromboembolism(Every 3 three days, from ICU day 2 to 17)
- Patient-days under light sedation or alert and calm (RASS - 3 to 0)(Every 3 three days, from ICU day 2 to 17)
- Rate of central-line catheter use(Daily from ICU day 2 to 17)
- Indwelling urinary catheter use rate(Daily from ICU day 2 to 17)
- Safety Attitudes Questionnaire Score(In phase 1, between sept/2013 and january/2014 each ICU staff answered the questionnaire once. In phase 2, between july/2014 and december/2014 the questionnaire was applied again (once for each ICU staff).)
- ICU mortality(ICU discharge; follow-up limited to 60 days)
- Central line-associated bloodstream infection (CLABSI) rate(Daily from ICU day 2 to 17)
- Length of hospital stay(Hospital discharge; average of 20 days; follow-up limited to 60 days)
- Mechanical ventilation-free days at 28 days(Day 28 after ICU admission)
- Urinary tract infection associated with catheter rate(Daily from ICU day 2 to 17)
- Ventilator-associated pneumonia (VAP)(Daily from ICU day 2 to 17)
- Length of ICU stay(Hospital discharge; follow-up limited to 60 days)
- Rate of patients receiving enteral or parenteral feeding(Every 3 three days, from ICU day 2 to 17)
- Tidal volume <=8mL/kg of predicted body weight in patients on mechanical(Every 3 three days, from ICU day 2 to 17)